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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

Short name DUAL™ VIII

NCTNCT02501161 (opens ClinicalTrials.gov in a new tab)Other idNN9068-4228Other id2014-005639-15Other idU1111-1165-3914Other id2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,012 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
16 countries

United States, Argentina, Brazil, Czechia, Hungary, India, Israel, Italy, Mexico, Norway, Poland, Russia, Slovakia, South Africa, Turkey (Türkiye), United Kingdom

Start
31 Jan 2016
Primary completion
3 Oct 2018
Completion
3 Oct 2018
First posted
17 Jul 2015 (estimated)
Last update posted
27 Nov 2019
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph 3

    DUAL™ VIII

    NCT02501161

    31 Jan 2016 to 3 Oct 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.

Interventions

  • insulin degludec/liraglutideDrug
  • insulin glargineDrug

Arms2

  • Experimental

    Insulin degludec/liraglutide QD + OAD(s)

  • Active comparator

    insulin glargine QD + OAD(s)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification

    Time frame · Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

    Registry description

    Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.

Secondary outcomes(20)

  1. Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits

    Time frame · Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

    Registry description

    Time to HbA1c \> 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c \> 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was \> 6.5% at week 12). Time from randomisation to HbA1c \>6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c \< 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function.

  2. Change in HbA1c

    Time frame · Week 0, week 26

    Registry description

    Change in HbA1c from baseline (week 0) to week 26 is presented.

  3. Change in Body Weight

    Time frame · Week 0, week 26, week 104

    Registry description

    Change in body weight from baseline (week 0) to week 26 and week 104 is presented.

  4. Insulin Dose

    Time frame · Week 26, week 104

    Registry description

    Insulin dose after 26 and 104 weeks of treatment is presented.

  5. Participants Who Achieved (Yes/no): HbA1c <7.0%

    Time frame · Week 26, week 104

    Registry description

    Percentage of participants who achieved (yes/no) HbA1c \<7.0% at week 26 and week 104 is presented.

  6. Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain

    Time frame · Week 26, week 104

    Registry description

    Percentage of participants who achieved (yes/no) HbA1c \<7.0% without weight gain at week 26 and week 104 is presented.

  7. Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

    Time frame · Week 26, week 104

    Registry description

    Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.

  8. Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain

    Time frame · Week 26, week 104

    Registry description

    Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.

  9. Participants Who Achieved (Yes/no): HbA1c ≤6.5%

    Time frame · Week 26, week 104

    Registry description

    Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented.

  10. Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain

    Time frame · Week 26, week 104

    Registry description

    Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented.

  11. Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

    Time frame · Week 26, week 104

    Registry description

    Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.

  12. Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain

    Time frame · Week 26, week 104

    Registry description

    Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.

  13. Change in FPG

    Time frame · Week 0, week 26, week 104

    Registry description

    Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented.

  14. SMPG-9-point Profile (Individual Points in the Profile)

    Time frame · Week 26, week 104

    Registry description

    Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented.

  15. Change in SMPG-mean 9-point Profile

    Time frame · Week 0, week 26, week 104

    Registry description

    Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean 9-point profile from baseline (week 0) to week 26 and week 104 is presented.

  16. Change in SMPG-mean Postprandial Increment Over All Meals

    Time frame · Week 0, week 26, week 104

    Registry description

    Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 and week 104 is presented.

  17. Change in Blood Pressure (Systolic and Diastolic)

    Time frame · Week 0, week 26, week 104

    Registry description

    Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented.

  18. Change in Fasting C-peptide

    Time frame · Week 0, week 26, week 104

    Registry description

    Change in fasting C-peptide (measured in nanomoles per liter \[nmol/L\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.

  19. Change in Fasting Human Insulin

    Time frame · Week 0, week 26, week 104

    Registry description

    Change in fasting human insulin (measured in picomoles per liter \[pmol/L\]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.

  20. Change in Fasting Total Cholesterol

    Time frame · Week 0, week 26, week 104

    Registry description

    Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification

GroupValue (Weeks)
Insulin Degludec/LiraglutideNA
Insulin Glargine104.3
Secondary and other outcome results(7)
Secondary outcomeMedian· Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2

Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits

GroupValue (Weeks)
Insulin Degludec/LiraglutideNA
Insulin Glargine64.1
Secondary outcomeMean· Week 0, week 26

Change in HbA1c

GroupValue (Percentage of HbA1c)Spread
Insulin Degludec/Liraglutide-1.991.14
Insulin Glargine-1.691.10
Secondary outcomeMean· Week 0, week 26, week 104

Change in Body Weight

GroupValue (Kilogram (kg))Spread
Insulin Degludec/Liraglutide0.53.3
Insulin Glargine2.23.6
Secondary outcomeMean· Week 26, week 104

Insulin Dose

GroupValue (Units)Spread
Insulin Degludec/Liraglutide34.613.4
Insulin Glargine48.628.2
Secondary outcomeNumber· Week 26, week 104

Participants Who Achieved (Yes/no): HbA1c <7.0%

GroupValue (Percentage of participants)
Insulin Degludec/Liraglutide78.7
Insulin Glargine55.7
Secondary outcomeNumber· Week 26, week 104

Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain

GroupValue (Percentage of participants)
Insulin Degludec/Liraglutide38.5
Insulin Glargine15.4
Secondary outcomeNumber· Week 26, week 104

Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

GroupValue (Percentage of participants)
Insulin Degludec/Liraglutide71.3
Insulin Glargine44.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Insulin Degludec/LiraglutideParticipants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).2 / 50660 / 506206 / 506
Insulin GlargineParticipants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached.5 / 50443 / 504156 / 504

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2024

6 results

Higher Derived Time in Range With IDegLira Versus Insulin Glargine U100 in People With Type 2 Diabetes.

Philis-Tsimikas et al. 2024Journal of diabetes science and technologycited by 8

PMID 36710452PMC11089877DOI 10.1177/19322968221149041PUB-36710452

Free to read · publisher termsCC BY-NC6 results
Read at sourceSee results (6)

Indexing hint: Randomized controlled trial · 2019

5 results

Durability of insulin degludec plus liraglutide versus insulin glargine U100 as initial injectable therapy in type 2 diabetes (DUAL VIII): a multicentre, open-label, phase 3b, randomised controlled trial.

Aroda et al. 2019The lancet. Diabetes & endocrinologycited by 51

PMID 31189519DOI 10.1016/s2213-8587(19)30184-6PUB-31189519

Full text at the publisher5 results
Publisher pageSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female, age greater than or equal to 18 years at the time of signing informed consent * Subjects diagnosed with type 2 diabetes mellitus * HbA1c 7.0-11.0% (both inclusive) (53-97 mmol/mol) by central laboratory analysis * Body mass index greater than or equal to 20 kg/m\^2 * Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes * Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: a) Biguanides (metformin greater than or equal to 1500 mg or maximum tolerated dose documented in the subject medical record), b) Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subjects medical record) Exclusion Criteria: * Screening calcitonin greater than or equal to 50 ng/L * Renal impairment estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening * Impaired liver function, defined as ALAT or ASAT greater than or equal to 2.5 times upper limit of normal * Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma * History of pancreatitis (acute or chronic) * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening * Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

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